Amended Final Report on the Safety Assessment of Oryza Sativa (Rice) Bran Oil, Oryza Sativa (Rice) Germ Oil, Rice Bran Acid, Oryza Sativa (Rice) Bran Wax, Hydrogenated Rice Bran Wax, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Powder, Oryza Sativa (Rice) Starch, Oryza Sativa (Rice) Bran, Hydrolyzed Rice Bran Extract Hydrolyzed Rice Bran Protein, Hydrolyzed Rice Extract, and Hydrolyzed Rice Protein1

Abstract

This report addresses the safety of cosmetic ingredients derived from rice, Oryza sativa. Oils, Fatty Acids, and Waxes : Rice Bran Oil functions in cosmetics as a conditioning agent—occlusive in 39 formulations across a wide range of product types. Rice Germ Oil is a skin-conditioning agent—occlusive in six formulations in only four product categories. Rice Bran Acid is described as a surfactant— cleansing agent, but was not in current use. Rice Bran Wax is a skin-conditioning agent—occlusive in eight formulations in five product categories. Industry did not directly report any use of Rice Bran Wax. Hydrogenated Rice Bran Wax is a binder, skin-conditioning agent—occlusive, and viscosity-increasing agent—nonaqueous in 11 formulations in six product categories. Rice Bran Oil had an oral LD50 of >5 g/kg in white rats and Rice Wax had an oral LD50 of > 24 g/kg in male mice. A three-generation oral dosing study reported no toxic or teratologic effects in albino rats fed 10% Rice Bran Oil compared to a control group fed Peanut Oil. Undiluted Rice Bran Oil, Rice Germ Oil, and Hydrogenated Rice Bran Wax were not irritants in animal skin tests. Rice Bran Oil was not a sensitizer. Rice Bran Oil, Rice Germ Oil, Rice Wax, and Hydrogenated Rice Bran Wax were negative in ocular toxicity assays. A mixture of Rice Bran Oil and Rice Germ Oil had a ultraviolet (UV) absorption maximum at 315 nm, but was not phototoxic in a dermal exposure assay. Rice Bran Oil was negative in an Ames assay, and a component, -oryzanol, was negative in bacterial and mammalian mutagenicity assays. Rice oils, fatty acids, and waxes were, at most, mildly irritating in clinical studies. Extracts : Rice Bran Extract is used in six formulations in four product categories. Rice Extract is a hair-conditioning agent, but was not in current use. Hydrolyzed Rice Extract is used in four formulations and current concentration of use data were provided for other uses. Hydrolyzed Rice Bran Extract, described as a skin-conditioning agent—miscellaneous, is used in two product categories. Use concentrations are in the 1% to 2% range. Rice Bran Extract is comprised of proteins, lipids, carbohydrates, mineral ash, and water. The content includes palmitic, stearic, oleic, and linoleic acids. Other components include antioxidants such as tocopherols. Rice Extract reduced the cytotoxicity of sodium chloride in male rats. Bran, Starch and Powder : Rice Bran (identified as rice hulls) is an abrasive and bulking agent in one formulation. Rice Starch is an absorbent and bulking agent in 51 formulations across a wide range of product categories. Rice Germ Powder is an abrasive and one manufacturer described an exfoliant use, but it was not reported to be used in 2002. Oral carcino-genicity studies done on components of Rice Bran (phytic acid and -oryzanol) were negative. Rice Bran did not have an anticarcinogenic effect on 1,2-dimethylhydrazine-induced large bowel tumors. In cocarcinogenicity studies done using 1,2-dimethylhydrazine and other agents, with Rice Bran Oil and Rice Bran-derived hemicellulose and saccharide, tumor inhibition was observed; -oryzanol did not inhibit the development of neoplasms. A decrease in cutaneous lesions in atopic dermatitis patients was reported following bathing with a Rice Bran preparation. Proteins : Hydrolyzed Rice Bran Protein and Hydrolyzed Rice Protein function as conditioning agents (hair or skin), but only the latter was reported to be used in a few products. An in vitro phototoxicity assay using UVA light found no photochemical toxicity. Rice bran protein hydrolysates are not acutely toxic, are not skin or ocular irritants in animals, are not skin sensitizers in guinea pig maximization tests, and are not irritating or sensitizing in clinical tests. Isolated cases of allergy to raw rice have been reported, but rice, in general, is considered nonallergenic. The Cosmetic Ingredient Review (CIR) Expert Panel considered that safety test data available on certain of these ingredients could be extrapolated to the entire group. Although Rice Bran Extract does contain UV absorbing compounds at low concentrations, clinical experience suggested no phototoxi-city would be associated with such materials. Rice derived ingredients generally are considered to be nonallergenic. There were no safety test data available for Hydrolyzed Rice Extract and Hy-drolyzed Rice Bran Extract, but their safety may be inferred from that of the extracts from which they are derived. Current levels of polychlorinated biphenyls (PCBs) and heavy metals in rice-derived ingredients used in cosmetics are not a safety concern. The Panel was concerned, however, that contaminants such as pesticides have been reported in Rice Bran Oil used for cooking. Pesticides and heavy metals should not exceed currently reported levels for ricederived cosmetic ingredients. The CIR Expert Panel concluded that these rice-derived ingredients are safe as cosmetic ingredients in the practices of use and concentrations as described in this safety assessment.